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Avapro

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Avapro

INDICATIONS

Hypertension

AVAPRO (irbesartan) is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents.

Nephropathy In Type 2 Diabetic Patients

AVAPRO is indicated for the treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria ( > 300 mg/day) in patients with type 2 diabetes and hypertension. In this population, AVAPRO reduces the rate of progression of nephropathy as measured by the occurrence of doubling of serum creatinine or end-stage renal disease (need for dialysis or renal transplantation) (see: Clinical Studies).

DOSAGE AND ADMINISTRATION

AVAPRO may be administered with other antihypertensive agents and with or without food.

Hypertension

The recommended initial dose of AVAPRO (irbesartan) is 150 mg once daily. Patients requiring further reduction in blood pressure should be titrated to 300 mg once daily.

A low dose of a diuretic may be added, if blood pressure is not controlled by AVAPRO alone. Hydrochlorothiazide has been shown to have an additive effect (see: Clinical Studies). Patients not adequately treated by the maximum dose of 300 mg once daily are unlikely to derive additional benefit from a higher dose or twice-daily dosing.

No dosage adjustment is necessary in elderly patients, or in patients with hepatic impairment or mild to severe renal impairment.

Nephropathy In Type 2 Diabetic Patients

The recommended target maintenance dose is 300 mg once daily. There are no data on the clinical effects of lower doses of AVAPRO on diabetic nephropathy (see : Clinical Studies).

Volume-And Salt-Depleted Patients

A lower initial dose of AVAPRO (75 mg) is recommended in patients with depletion of intravascular volume or salt (eg, patients treated vigorously with diuretics or on hemodialysis) (see WARNINGS: Hypotension in Volume-or Salt-Depleted Patients).

HOW SUPPLIED

AVAPRO® (irbesartan) is available as white to off-white biconvex oval tablets, debossed with a heart shape on one side and a code on the other (see Table below). Unit-of-use bottles contain 30 or 90 tablets as follows:

  75 mg 150 mg 300 mg
Debossing 2871 2872 2873
Bottle of 30 0024-5850-30 0024-5851-30 0024-5852-30
Bottle of 90 0024-5850-90 0024-5851-90 0024-5852-90

Storage

Store at 25°C (77°F); excursions permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature].

sanofi-aventis U.S. LLC Bridgewater, NJ 08807. A SANOFI COMPANY. Rev May 2014

Last reviewed on RxList: 7/15/2014
This monograph has been modified to include the generic and brand name in many instances.

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Avapro - User Reviews

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Hypertension

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